Product Development Services
Our new 40,000 sq.ft. Science Center offers a complete range of drug development services, analytical methods development, methods and process validation, ANDA/NDA product submissions, suitability petitions, raw material and finished product and stability testing. Our well trained staff understands the importance of speed, accuracy, and responsiveness. We provide all the resources necessary to take your product from formulation development to commercial production.
Mikart offers the following services to support your product development requirements:
- Analytical Testing
- Methods Development, refinement, & validation
- Raw Material Testing
- Active Pharmaceutical ingredient testing
- Cleaning validation
- Stability testing and storage
- Environmental monitoring and support
- Candidate selection
- Feasibility studies
- Technology transfer
- Process validation
- Clinical supply manufacturing, packaging, and labeling
- Pre-formulation, formulation, and process development of multiple oral dosage forms
- Drug delivery systems
- Regulatory planning and consulting
- Review and counsel on clinical, CMC, and bioanalytical issues
- Submission assembly and preparation
- Planning for and representation at meetings with regulatory authorities
- Agency response preparation
- Regulatory and technical management
- Instrument, equipment, and facility qualification/validation
Our specialty is in providing turn-key solutions to our customer's needs; however we also offer the advantage of selecting services on an individual basis.
